JP7023508B2 - Manufacturing method of ankle foot orthotic device and ankle foot orthotic device - Google Patents

Description

The present invention relates to a method for manufacturing an ankle foot orthotic device and an ankle foot orthotic device. More specifically, the present invention relates to a method for manufacturing an ankle foot orthotic device that supports proper walking by promoting the supination action and the inward action of the foot, and the ankle foot orthotic device.

Hemiplegia or peripheral nerve palsy due to stroke, cerebral hemorrhage, or cerebral infarction can cause ankle joint inability to move freely. Patients with such disabilities cannot move their weight smoothly because their toes hang down when walking (hanging feet), which makes walking difficult.

Conventionally, for patients with such symptoms of drooping feet, the toes are caught on the floor and the walking is hindered. Therefore, the ankle foot orthotic device is generally used as an auxiliary tool for realizing a healthy walking. Has been done.

As such an ankle foot orthotic device, a metal ankle foot orthotic device has been mainly used in the past. However, the metal ankle foot orthotic device was heavy, did not always look good, and was not easy to use.

Therefore, in recent years, ankle foot orthotic devices made of plastic or synthetic resin, which are lightweight and look good, have become the mainstream.

For example, Patent Document 1 discloses an ankle foot orthotic device which is made of a relatively hard synthetic resin and in which a sole plate portion on which the sole is placed and a lower leg mounting portion mounted on the lower leg are continuously integrally molded. Has been done. According to this ankle foot orthotic device, the weight of the entire device is reduced and the appearance is improved, and since the sole plate part and the lower leg mounting part are integrally molded, the ankle plantar flexion motion (toe hangs down). Both bending) and dorsiflexion (bending in the direction that the toes are lifted) are blocked, and it is possible to correct the drooping leg.

However, as in the ankle foot orthotic device described in Patent Document 1, if the ankle joint is firmly fixed and both the plantar flexion movement and the dorsiflexion movement are blocked, the ankle joint becomes almost immobile and walking. Has the drawback of being unnatural. In particular, for patients in the acute phase and the convalescent phase who start walking training, training with such ankle foot orthotic device may conversely hinder recovery.

Therefore, for example, Patent Document 2 discloses an ankle foot orthotic device having an auxiliary function for assisting the plantar flexion motion of the foot after the heel of the patient is placed on the ground.

Specifically, the ankle foot orthotic device is composed of a lower leg mounting portion, a sole plate portion mounted on the sole of the foot, a damper, and a connecting shaft, and a guide block, a link, and an ankle foot orthotic device are attached to the movable end of the damper. Has a guide rail that extends in the anterior-posterior direction of the patient when mounted on the patient. The lower end of the link is fixed to the sole plate, and the upper end is slidably engaged with the guide rail. In such a connecting mechanism, the link engaged with the guide rail in conjunction with the swing of the sole plate portion is fixed to the lower leg mounting portion by moving the guide block linearly along the longitudinal direction of the lower leg. The damper is functioning, and it is possible to assist the plantar flexion movement of the foot after the heel is placed on the ground.

In addition, with the progress of material development in recent years, carbon (carbon fiber reinforced plastic) as a material that is lighter than plastic or synthetic resin and has excellent strength is attracting attention, and the bottom dorsiflexion made of carbon as a material. The present inventor has proposed an ankle foot equipment capable of exercise (Patent Document 3) and a method for manufacturing the same (Patent Document 4).

Japanese Unexamined Patent Publication No. 9-103443 Japanese Unexamined Patent Publication No. 2011-98014 Japanese Unexamined Patent Publication No. 2017-196187 Japanese Unexamined Patent Publication No. 2016-107614

By the way, the movement of the ankle actually progresses while the plantar dorsiflexion movement of the ankle joint rotates slightly in the supination and inward directions. This is due to the difference in height between the inner ankle (inner malleolus) and the outer malleolus (outer malleolus) of the ankle (the outer malleolus is located closer to the ground than the inner malleolus).

However, in the ankle foot orthotic device disclosed in Patent Document 2 and Patent Document 3, the attachment position of the lower leg mounting portion that holds the calf portion of the foot and the connecting portion that connects the sole plate portion that holds the sole of the foot is different. It did not take into account the height positions of the inner and outer fruits.

That is, since the outer fruit is located on the side closer to the ground side with respect to the inner fruit, the virtual straight line connecting the inner fruit and the outer fruit has a predetermined inclination angle with respect to the horizontal axis. Therefore, the center position of the connection part on the outer malleolus side should be located closer to the ground than the center position of the connection part on the inner fruit side. The connection part on the inner fruit side and the connection part on the outer fruit side were attached at the same height position. Therefore, not only the supination action and the supination action associated with the smooth plantar dorsiflexion movement are hindered and appropriate rehabilitation exercise cannot be performed, but also it causes discomfort and pain when wearing the ankle foot orthotic device.

The present invention has been devised in view of the above points, and provides a method for manufacturing an ankle foot orthotic device that supports proper walking by promoting the supination action and the inward action of the foot, and an ankle foot orthotic device. The purpose is to provide.

In order to achieve the above object, the method for manufacturing an ankle foot orthotic device of the present invention includes a step of wrapping a cast on the affected foot and molding it into the shape of the affected foot, and the cured cast of the cast from the affected foot. In the process of removing and molding a negative model, and in the negative model, a hole is formed in the inner malleolus at a position substantially corresponding to the inner fruit end point of the affected foot, and an outer fruit hole is formed at a position substantially corresponding to the outer fruit end point of the affected foot. A step of setting, a step of inserting a rod-shaped member from either one side of the inner fruit hole portion or the outer fruit hole portion toward the other side, and a step of pouring plaster into the negative model and curing it to obtain a positive model. In the step of molding, one end side of the rod-shaped member is inserted into a through hole formed at a predetermined position of the first dummy portion made of a plate-shaped body, and the first dummy portion is placed inside the foot of the positive model. In the step of attaching, the other end side of the rod-shaped member is inserted into a through hole formed at a predetermined position of the second dummy portion made of a plate-shaped body, and the second dummy portion is placed on the outer side of the foot of the positive model. A thermoplastic model is molded by a step of attaching, a step of extracting the rod-shaped member from the positive model, a step of coating the positive model with a laminate, and a step of covering the positive model with a thermoplastic sheet and vacuum molding. It comprises a step and a step of removing the thermoplastic model from the positive model.

Here, by wrapping a cast bandage around the affected foot and providing a step of molding the shape of the affected foot, the cast bandage can be molded into the shape of the affected foot. At this time, by manually pressing the positions substantially corresponding to the inner fruit end point, the outer fruit end point, and the Achilles tendon portion, it is possible to form a more accurate shape.

Further, by providing a step of removing the hardened cast bandage from the affected foot and molding a negative model, it is possible to mold a negative model that matches the shape of the affected foot for molding a positive model described later.

Further, in the negative model, a step of piercing the inner fruit hole portion at a position substantially corresponding to the inner fruit end point of the affected foot and the outer fruit hole portion at a position substantially corresponding to the outer fruit end point of the affected foot is provided. The inner and outer fruit endpoints can be aligned in the model.

By providing a step of inserting the rod-shaped member from either one side of the inner fruit hole portion or the outer fruit hole portion toward the other side, the first dummy portion and the second dummy portion, which will be described later, are designated as a negative model. A rod-shaped member for mounting in the position of can be installed in the negative model.

Further, by providing a step of pouring gypsum into the negative model, curing it, and molding a positive model, it is possible to mold a positive model that matches the shape of the affected foot for molding a thermoplastic model described later.

Further, by providing a step of inserting one end side of the rod-shaped member into a through hole formed at a predetermined position of the first dummy portion made of a plate-shaped body and attaching the first dummy portion to the inside of the foot of the positive model. , The first dummy portion imitating the in-foot connecting portion described later can be accurately attached to the medial side of the foot of the positive model.

Further, a step of inserting the other end side of the rod-shaped member into a through hole formed at a predetermined position of the second dummy portion made of a plate-shaped body and attaching the second dummy portion to the outside of the foot of the positive model is provided. As a result, the second dummy portion imitating the extrafoot connection portion described later can be accurately attached to the lateral side of the foot of the positive model.

In addition, by providing a step of extracting the rod-shaped member from the positive model, the inner fruit hole portion is positive at the position substantially corresponding to the inner fruit end point of the affected foot, and the outer fruit hole portion is positive at the position substantially corresponding to the outer fruit end point of the affected foot. Can be formed into a model.

Further, by providing the positive model with a step of coating the laminate, it is possible to prevent the thermoplastic sheet used for vacuum forming, which will be described later, from coming into direct contact with the positive model, so that a thermoplastic model having a more accurate shape can be obtained. Can be molded.

Further, by providing a step of forming a thermoplastic model by covering the positive model with a thermoplastic sheet and vacuum forming it, it is possible to form a thermoplastic model made of a thermoplastic tree material using the positive model as a mold. ..

Further, by providing the step of removing the thermoplastic model from the positive model, the thermoplastic model can be removed from the positive model.

In addition, if the step of removing the thermoplastic model from the positive model includes a step of making a cut along the circumferential direction of the thermoplastic model and separating the thermoplastic model into the sole mounting portion and the lower leg mounting portion, heat is provided. When removing the thermoplastic model from the positive model, the thermoplastic model can be separated into a sole-mounted part and a lower leg-mounted part.

In addition, the step of separating the thermoplastic model into the lower leg mounting portion and the sole mounting portion is the position corresponding to the first dummy portion, and the medial foot recess recessed in the thermoplastic model is located on the sole mounting portion side. The foot sole mounting portion is separated into the first foot medial recess and the second foot medial recess on the lower leg mounting portion side, and the foot lateral recess corresponding to the second dummy portion and recessed in the thermoplastic model. When the step of separating into the first foot lateral recess on the side and the second foot lateral recess on the lower leg mounting portion side is included, the inward connection described later to the first foot medial recess and the second foot medial recess. The portion can be fitted and attached, and the extrafoot connecting portion described later can be fitted and attached to the first foot lateral recess and the second foot lateral recess.

Further, the step of attaching the first dummy portion to the inside of the foot of the positive model includes a step of interposing a first spacer between the first dummy portion and the positive model, and the second dummy portion is of the positive model. When the step of attaching to the lateral side of the foot includes a step of interposing a second spacer between the second dummy portion and the positive model, the first spacer and the second spacer are used to make the positive model and the first spacer. A certain space can be provided between the dummy portion and the second dummy portion. This makes it possible to prevent direct contact between the ankle foot orthotic device after molding and the inner and outer malleolus of the affected foot, and to realize a smoother plantar dorsiflexion movement.

Further, if there is a step of wrapping a wrap film around the positive model after the step of extracting the rod-shaped member from the positive model and before the step of coating the laminate on the positive model, the laminate is attached to the positive model. It is possible to prevent the laminate from absorbing the water contained in the plaster of the positive model when the coating is applied.

Further, after the step of coating the laminate on the positive model and before the step of molding the thermoplastic model by vacuum forming, a third dummy having a substantially columnar shape at a position substantially corresponding to the Achilles tendon portion of the positive model. When the step of attaching the portion is provided, it is possible to form a space for attaching the pressing portion and the pressing receiving portion, which will be described later, as a braking member during the plantar flexion motion.

Further, in the step of removing the thermoplastic model from the positive model, the cylindrical portion formed along the shape of the third dummy portion is divided into a first cylindrical portion on the sole mounting portion side and a second cylinder on the lower leg mounting portion side. When the step of separating into the portions is provided, the pressing portion serving as the plantar flexion braking member can be attached to the first cylindrical portion and the pressing portion can be attached to the second cylindrical portion, respectively, as described later.

In order to achieve the above object, the ankle foot device of the present invention has a sole mounting portion mounted on the sole portion, a lower leg mounting portion mounted on the lower leg portion, and one side of the foot of the sole mounting portion. The medial side and the other side are connected to the medial side of the foot of the lower leg mounting portion, and the inward connecting portion having a rotation axis at a position substantially corresponding to the inner malleolus end point, one side is the lateral side of the sole mounting portion, and the other side is the lower leg. It is provided with an extrafoot connecting portion that is connected to the outer side of the foot of the mounting portion and has a rotation axis at a position substantially corresponding to the outer malleolus end point.

Here, one side is connected to the medial side of the sole mounting portion, and the other side is connected to the medial side of the lower leg mounting portion. The portion and the sole mounting portion can be connected by the in-foot connecting portion. At this time, since the rotation axis of the in-foot connection portion is located at a position substantially corresponding to the inner fruit end point of the affected foot, the supination and inward actions of the affected foot are not hindered and smooth plantar dorsiflexion movement is realized. be able to.

Further, one side is connected to the outside of the foot of the sole mounting portion, and the other side is connected to the outside of the foot of the lower leg mounting portion. And the sole mounting portion can be connected by the foot outer connecting portion. At this time, since the rotation axis of the extrafoot connecting portion is located at a position substantially corresponding to the outer malleolus end point of the affected foot, the supination and pronational actions of the affected foot are not hindered and smooth plantar dorsiflexion movement is realized. be able to.

Further, the in-foot connecting portion includes a first in-foot connecting portion connected to the medial side of the sole mounting portion on one side, and a second in-foot connecting portion connected to the medial side of the foot mounting portion on one side. , When the other side facing one side of the first in-foot connecting portion and the other side facing one side of the second in-foot connecting portion are fastened by the fastening portion at a position substantially corresponding to the inner fruit end point. Since the rotation axes of the first in-foot connection part and the second in-foot connection part are located at positions substantially corresponding to the inner fruit end points of the affected foot, the circumflexion action and the circumflexion action of the affected foot are hindered. It is possible to realize a smooth plantar dorsiflexion movement.

Further, the extrafoot connection portion includes a first extrafoot connection portion connected to the outside of the foot of the sole mounting portion on one side, and a second extrafoot connection portion connected to the outside of the foot of the lower leg mounting portion on one side. , When the other side facing one side of the first outer foot connecting portion and the other side facing one side of the second outer foot connecting portion are fastened by the fastening portion at a position substantially corresponding to the outer fruit end point. Since the rotation axes of the first extrafoot connection part and the second extrafoot connection part are located at positions substantially corresponding to the outer malleolus end points of the affected foot, the circumflexion action and the circumflexion action of the affected foot are hindered. It is possible to realize a smooth plantar dorsiflexion movement.

Further, the in-foot connecting portion is a second in-foot step portion, which is the other side of the first in-foot connecting portion and is formed from the first in-foot convex portion and the first in-foot concave portion. When the second in-foot step portion formed from the second in-foot convex portion and the second in-foot concave portion on the other side of the in-foot connecting portion is unevenly fitted so as to mesh with each other in a staggered manner. Can make the fitted state of the first in-foot connecting portion and the second in-foot connecting portion stronger.

Further, the foot outer connecting portion is a first outer foot step portion and a second foot outer step portion formed from the first foot outer convex portion and the first foot outer concave portion on the other side of the first foot outer connecting portion. When the second foot outer step portion formed from the second foot outer convex portion and the second foot outer concave portion on the other side of the foot outer connecting portion is unevenly fitted so as to mesh with each other in a staggered manner. Can make the fitted state of the first outer foot connecting portion and the second outer foot connecting portion stronger.

In addition, the virtual straight line connecting the rotation axis of the in-foot connection part and the rotation axis of the out-of-foot connection part has an inclination angle of about 8 to 13 ° with respect to the horizontal axis, and is the inner fruit end point and the outer side of the affected foot. Since the inclination can be approximated to a virtual straight line connecting the fruit end points, smooth plantar dorsiflexion movement is realized without hindering the supination and inward movements of the affected foot even when the ankle foot device is worn. be able to.

Further, a pressing portion made of an elastic material is provided at a position substantially corresponding to the Achilles tendon portion of the lower leg mounting portion, and a pressing receiving portion that is pressed by the pressing portion and is elastically deformable at a position substantially corresponding to the Achilles tendon portion of the sole mounting portion. In the case of having a plantar flexion braking part including, when walking with the ankle foot orthotic device attached to the affected foot, the pressing part presses the pressing receiving part when the affected foot lands on the ground, so that the pressing receiving part becomes It is compressed and deformed by a predetermined amount. Due to this deformation, the ankle joint flexes by a predetermined angle, so that the impact at the time of landing of the affected foot is absorbed and smooth walking can be realized.

The method for manufacturing an ankle foot orthotic device and the ankle foot orthotic device according to the present invention can support proper walking by promoting the supination action and the inward action of the foot.

It is a front perspective view of the ankle foot orthotic device which concerns on embodiment of this invention. It is a side view of the ankle foot orthotic device which concerns on embodiment of this invention. It is an exploded enlarged view of the connecting part of the ankle foot orthotic device which concerns on embodiment of this invention. It is a back view of the ankle foot orthotic device which concerns on embodiment of this invention. It is a figure which shows the manufacturing process of the ankle foot orthotic device which concerns on embodiment of this invention.

Hereinafter, a method for manufacturing an ankle foot orthotic device and an embodiment of the present invention relating to the ankle foot orthotic device will be described with reference to the drawings, and the present invention will be understood. In each figure, for convenience of explanation, when the ankle foot device 1 is attached to the affected foot of the patient, the direction from the bottom of the foot to the lower leg is upward, and the opposite direction of the upward direction is downward and upward. , And the axial direction represented by the downward direction is defined as the vertical axis, and the axial direction perpendicular to the vertical axis is defined as the horizontal axis.

First, the overall configuration of the ankle foot orthotic device 1 according to the embodiment to which the present invention is applied will be described with reference to FIGS. 1 to 4. For convenience of explanation, the ankle foot orthotic device 1 for the right foot will be described here. The ankle foot orthotic device 1 is made of a thermoplastic synthetic resin material, and is mainly composed of a sole mounting portion 2, a lower leg mounting portion 3, an inward connecting portion 4, an external connecting portion 5, and a plantar flexion braking portion 6. ..

The sole mounting portion 2 covers the foot resting portion 21 on which the sole of the affected foot is placed, the medial malleolus, the lateral malleolus, and the Achilles tendon of the affected foot, and the foot is erected from the foot resting portion 21 along the vertical axis. It is composed of a covering portion 22.

At the upper end of the medial side of the foot of the foot covering portion 22, a first medial foot medial recess 23 into which the first intrafoot connecting portion 41, which is a part of the inward connecting portion 4 described later, is inserted is recessed. A second foot lateral recess 24 into which the first foot outer connecting portion 51, which is a part of the foot outer connecting portion 5, which will be described later, is inserted is recessed in the upper end portion of the foot outer side of the foot covering portion 22. There is.

Further, at a position substantially corresponding to the Achilles tendon portion of the foot covering portion 22, a pressure receiving portion 62 which is a part of the plantar flexion braking portion 6 described later is fitted and an open end which opens upward is formed. It also has a first cylindrical portion 61. The pressing receiving portion 62 to be fitted and inserted into the first cylindrical portion 61 is made of, for example, a synthetic resin material, and has a configuration capable of elastic deformation when pressed by the pressing portion 64 described later.

The lower leg mounting portion 3 is a rear support type, has a substantially U-shaped cross section with the front side open, and abuts on the rear surface contact portion 31 of the lower leg that abuts on the rear surface of the lower leg and both side surfaces of the lower leg portion. The lower leg side contact portion 32 is integrally formed.

Here, the lower leg mounting portion 3 does not necessarily have to be a rear support type that supports the rear surface of the lower leg portion. For example, it may be a front support type lower leg mounting portion having a lower leg front contact portion that abuts the front surface of the lower leg portion and the rear surface side is open. However, in the ankle foot orthotic device 1 according to the embodiment of the present invention, the plantar flexion braking portion 6 for realizing smooth walking motion is mounted at a position substantially corresponding to the Achilles tendon portion on the back surface of the lower leg mounting portion 3. .. Therefore, from the viewpoint of securing the mounting space for the plantar flexion braking portion 6, the lower leg mounting portion 3 is preferably a rear support type.

At the lower end of the medial side of the foot of the lower leg mounting portion 3, a first medial foot medial recess 33 into which the second intrafoot connecting portion 42, which is a part of the in-foot connecting portion 4 described above, is fitted is recessed. A second foot lateral recess 34 into which the second foot outer connecting portion 52, which is a part of the above-mentioned outer foot connecting portion 5, is inserted is recessed in the lower end portion of the lower leg mounting portion 3. Has been done.

Further, a pressing portion 64, which is a part of the plantar flexion braking portion 6 described later, is inserted and inserted at a position substantially corresponding to the Achilles tendon portion of the lower leg mounting portion 3, and is opened downward and the first described above. It has a second cylindrical portion 63 having an open end facing the open end of the cylindrical portion 61. The pressing portion 64 to be fitted and inserted into the second cylindrical portion 63 is made of, for example, a synthetic resin material, and has a configuration capable of pressing against the above-mentioned pressing receiving portion 62 during a plantar flexion motion.

The sole mounting portion 2 and the lower leg mounting portion 3 have a first belt body 25 and a second belt body 35 for fixing the affected foot to the ankle foot orthotic device 1. The first belt body 25 and the second belt body 35 are flexible belt members having a predetermined width and length, and one end side is a free end so that they can be engaged with, for example, a metal holder portion (not shown). The other end side is fixed to the sole mounting portion 2 and the lower leg mounting portion 3 by a known fixing means such as a rivet.

When the ankle foot orthotic device 1 is attached to the affected foot, the foot portion of the affected foot is attached to the sole attachment portion 2, and the lower leg portion of the affected foot is attached to the lower leg attachment portion 3, and then the first belt is attached. The free ends of the body 25 and the second belt body 35 are inserted into the holder portion, the tip end side is folded back, and the body 25 and the second belt body 35 are fixed at an arbitrary position by a fixing means such as a surface fastener.

Here, the first belt body 25 and the second belt body 35 do not necessarily have to be fixed at arbitrary positions by a hook-and-loop fastener or the like. For example, it may be configured to be locked in a predetermined fixed position. However, since it can be attached and detached at a variable position by the hook-and-loop fastener, the locking position can be appropriately selected according to the patient's pathological condition, the use of rehabilitation training, the situation, and the like.

The in-foot connecting portion 4 is a jig for connecting the medial side of the sole mounting portion 2 and the medial side of the lower leg mounting portion 3, and is a first in-foot connecting portion 41 made of a substantially rectangular plate-shaped body. And a second in-foot connecting portion 42.

As described above, the first in-foot connecting portion 41 is fitted into the first medial foot recess 23, and one end thereof is fixed to the upper end of the medial side of the foot of the sole mounting portion 2. Further, the second in-foot connecting portion 42 is fitted into the first medial foot medial recess 33, and one end thereof is fixed to the lower end portion of the medial foot of the lower leg mounting portion 3. The other ends of the first in-foot connecting portion 41 and the second in-foot connecting portion 42 are rotatably supported by the fastening portion 7.

The outer foot connecting portion 5 is a jig for connecting the outer side of the foot of the sole mounting portion 2 and the outer side of the foot of the lower leg mounting portion 3, and is a first outer foot connecting portion 51 made of a substantially rectangular plate-shaped body. And a second foot outer connecting portion 52.

The first foot outer connecting portion 51 is fitted into the second foot outer side recess 24, and one end thereof is fixed to the upper end portion of the foot outer side of the sole mounting portion 2. Further, the second outer foot connecting portion 52 is fitted into the second outer foot outer recess 34, and one end thereof is fixed to the lower end portion on the outer foot of the lower leg mounting portion 3. The other ends of the first outer foot connecting portion 51 and the second outer foot connecting portion 52 are rotatably supported by the fastening portion 7.

As shown in FIG. 4, the first in-foot connecting portion 41 and the second in-foot connecting portion 42 have a rotation axis a1 at a position substantially corresponding to the inner fruit end point of the affected foot, and the first foot. The outer connecting portion 51 and the second outer connecting portion 52 have a rotation axis a2 at a position substantially corresponding to the outer malleolus end point of the affected foot. At this time, the virtual straight line L connecting the rotation axis a1 and the rotation axis a2 has an inclination angle of approximately 8 to 13 ° with respect to the horizontal axis H.

Here, it is not always necessary to provide the rotation axes a1 and a2 at positions substantially corresponding to the inner fruit end points and the outer fruit end points. However, by providing the rotation axes a1 and a2 at positions substantially corresponding to the inner fruit end point and the outer fruit end point, the movement of the ankle foot orthotic device 1 can be made closer to the movement of the affected foot, and thus the supination of the affected foot. Smooth plantar dorsiflexion can be achieved without inhibiting the action or supination.

Next, the detailed structure of the in-foot connecting portion 4 and the out-of-foot connecting portion 5 will be described with reference to FIG. Since the in-foot connecting portion 4 and the out-of-foot connecting portion 5 have the same structure, the explanation will be based on the out-of-foot connecting portion 5 for convenience of explanation.

As shown in FIG. 3, at the other end of the first foot outer connecting portion 51 constituting the foot outer connecting portion 5, the first foot is provided by the first foot outer convex portion 511 and the first foot outer concave portion 512. An outer step portion 513 is formed. On the other hand, in the second foot outer connecting portion 52 as well as the first foot outer connecting portion 51, the second foot outer step portion 523 is formed by the second foot outer convex portion 521 and the second foot outer concave portion 522. Has been done.

Then, the first foot outer step portion 513 and the second foot outer step portion 523 are alternately meshed so that the first foot outer connecting portion 51 and the second outer foot connecting portion 52 form the same plane. After being fitted unevenly without any gaps, it is pivotally supported by the fastening portion 7. At this time, the joint surface between the first foot outer step portion 513 and the second foot outer step portion 523 is formed with an inclined surface inclined to the same slope.

Here, it is not always necessary that the first foot outer step portion 513 and the second foot outer step portion 523 are unevenly fitted. For example, the other ends of the first foot outer step portion 513 and the second foot outer step portion 523 may not be unevenly fitted to each other and may be pivotally supported by the fastening portion 7. However, since the uneven fitting makes the fastening between the first foot outer step portion 513 and the second foot outer step portion 523 stronger, it is preferable to adopt the uneven fitting structure.

Further, the first foot outer step portion 513 and the second foot outer step portion 523 are necessarily fitted so that the first foot outer connecting portion 51 and the second outer foot connecting portion 52 form the same plane. It does not have to be, and a step may be formed. However, since the first outer foot connecting portion 51 and the second outer foot connecting portion 52 are fitted so as to form the same plane, the outer foot connecting portion 5 can be installed even in a space-saving manner. ..

Further, it is not always necessary that the joint surface formed by the uneven fitting of the first foot outer step portion 513 and the second foot outer step portion 523 has an inclined surface inclined to the same slope. However, since the uneven fitting makes the fastening between the first foot outer step portion 513 and the second foot outer step portion 523 stronger, an inclined surface is formed on the joint surface of the uneven fitting. It is preferable that it is.

The first outer foot connecting portion 51 and the second outer foot connecting portion 52 fitted in an uneven manner are pivotally supported by a fastening portion 7 so as to be swingable. Specifically, the mounting hole 514 formed in the first foot outer convex portion 511 in a state where the first foot outer convex portion 511 and the second foot outer convex portion 521 are fitted by the uneven fitting. The mounting hole 524 formed in the second foot outer convex portion 521 is polymerized, and as shown in FIG. 3, the bolt 71a and the nut 72 are inserted and fixed.

The head of the bolt 71a is a countersunk screw and has a hexagonal hole that can be rotated by a hexagon wrench. The male screw has, for example, a pitch of about 0.5 mm.

The nut 72 is a disk having a flat head, and on the back surface of the head, a female screw into which a male screw of a bolt 71a can be screwed is screwed into the inner diameter, and a convex pillar having a substantially quadrangular cross section in outer shape. It has a part 721.

As a specific mounting method of the fastening portion 7, the bolt 71a is inserted into the mounting hole 514 and the mounting hole 524 from one side surface in a state where the mounting hole 514 and the mounting hole 524 are overlapped. Further, the convex pillar portion 721 of the nut 72 is inserted into the mounting hole 514 and the mounting hole 524 from the other side surface, and the male screw of the bolt 71a and the female screw of the nut 72 are screwed and tightened and fixed.

After the first outer foot connecting portion 51 and the second outer foot connecting portion 52 are fastened by the fastening portion 7, the outer foot connecting portion 5 is attached to the sole mounting portion 2 and the lower leg mounting portion 3 by bolts 71b and 71c. Fix it so that it cannot rotate.

Next, the plantar flexion braking unit 6 will be described. As described above, the plantar flexion braking portion 6 has a pressing portion 62 installed at a position corresponding to the Achilles tendon portion of the sole mounting portion 2 and a pressing portion 64 installed at a position corresponding to the Achilles tendon portion of the lower leg mounting portion 3. It is composed of.

In the plantar flexion braking unit 6 configured in this way, for example, when a human walks, the ankle joint is performed at once because the plantar flexion operation is performed while the press receiving portion 62 is gradually pressed by the pressing portion 64 after the heel lands. Can be prevented from bending to a predetermined angle. As a result, it is possible to absorb the impact at the initial stage of the stance phase, and it is possible to realize smooth walking.

The above is the ankle foot orthotic device 1 according to the embodiment of the present invention. Subsequently, a method for manufacturing the ankle foot orthotic device 1 according to the embodiment of the present invention will be described with reference to FIG.

<Step 1 Molding with a cast bandage>
Wrap a cast bandage around the affected foot to be modeled. After winding is complete, before the cast bandage hardens, hold the inner and outer malleolus points and the Achilles tendon by hand and mold the contours of each part. At this time, a guide string for cutting open the cast cast bandage is attached to the front side of the cast bandage.

<Process 2 Molding of negative model>
When the cast bandage is hardened in step 2, the guide string attached in advance is pulled, the cast bandage is cut open, the cast bandage is removed from the affected foot, and the negative model Mn is molded.

<Step 3 Installation of rod-shaped member>
A through hole (inner fruit hole) of about 4 mm at a position substantially corresponding to the inner fruit end point of the negative model Mn molded in the shape of the affected foot, and a through hole of about 4 mm at a position substantially corresponding to the outer fruit end point. (Outer fruit hole portion) is bored, and the rod-shaped member 8 is inserted into the through hole (see FIG. 5A).

<Process 4 Molding of positive model>
Gypsum G is poured into the negative model Mn (see FIG. 5A), and when the gypsum G is cured, the negative model Mn is stripped off and the positive model Mp is taken out.

<Installation of step 5 first dummy part (for foot connection part)>
A first dummy portion 10 having a shape corresponding to the in-foot connecting portion 4 and having a through hole formed in a substantially central portion is prepared. One end side of the rod-shaped member 8 penetrating the positive model Mp is inserted into the through hole of the first dummy portion 10 with a spacer 9 made of a silicon material or the like interposed therebetween, and the first dummy portion 10 is inserted into the positive model Mp. Attach to the tongue by fixing means such as nails. At this time, gypsum G is placed between the first dummy portion 11 and the positive model Mp and molded so as to have a smooth shape (see FIG. 5 (b)).

<Step 6 Installation of the second dummy part (for the foot connection part)>
A second dummy portion 11 having a shape corresponding to the foot outer connecting portion 5 and having a through hole formed in a substantially central portion is prepared. The other end side of the rod-shaped member 8 penetrating the positive model Mp is inserted into the through hole of the second dummy portion 11 with a spacer 9 made of a silicon material or the like interposed therebetween, and the second dummy portion 11 is inserted into the positive model. It is attached to Mp by a fixing means such as a nail, and gypsum G is placed between the second dummy portion 11 and the positive model Mp to form a smooth shape (see FIG. 5 (b)).

Here, it is not always necessary to interpose the spacer 9 when attaching the first dummy portion 10 and the second dummy portion 11 to the positive model. However, by interposing the spacer 9, a certain space can be provided between the positive model Mp, the first dummy portion 10, and the second dummy portion 11. As a result, direct contact between the ankle foot orthotic device 1 after molding and the inner and outer malleolus of the affected foot can be prevented, and a smoother plantar dorsiflexion movement can be realized. Therefore, the spacer 9 is interposed. Is preferable.

<Step 7 Removal of rod-shaped member>
After the attachment of the first dummy portion 10 and the second dummy portion 11 to the positive model Mp is completed in the steps 5 and 6, the alignment is confirmed and the rod-shaped member 8 is removed from the positive model Mp.

<Covering with a laminate of step 8 positive models>
As a pre-step for molding the thermoplastic model Mt, a wrap film is wrapped around the entire positive model Mp, the positive model Mp is covered with a laminate, and a mold release material (silicon spray or the like) is sprayed as necessary. This laminate is for absorbing a synthetic resin as a thermoplastic material, and can be appropriately selected from known materials such as carbon fiber, glass fiber, and nylon fiber. In the embodiment of the present invention, nylon stockinette was used as the laminated body.

Here, it is not always necessary to wrap the wrap film around the entire positive model Mp when coating with the laminate. However, by wrapping the wrap film, it is possible to prevent the water contained in the gypsum of the positive model Mp from appearing on the surface. Therefore, the finished molding of the thermoplastic model Mt can be made good.

<Step 9 Third dummy part (for plantar flexion braking part)>
After covering the positive model Mp with the laminated body, the mold of the first cylindrical portion 61 for attaching the pressing receiving portion 62 constituting the plantar bending braking portion 6 and the mold of the second cylindrical portion 63 for attaching the pressing portion 64. The third dummy portion 12 having a substantially cylindrical shape is fixed to the positive model Mp by a fixing means such as a nail (see FIG. 5 (b)).

<Process 10 Molding of thermoplastic model>
The positive model Mp coated with the laminate is coated so as to be wrapped with the thermoplastic sheet T made of a thermoplastic material, and the thermoplastic model Mt is molded by vacuum suctioning through the suction pipe S (see FIG. 5 (c)). .. At this time, the thermoplastic sheet T is previously heated in a heater such as an oven under a temperature condition of about 200 ° C. for 30 minutes and softened to some extent. In the embodiment of the present invention, a plastic sheet having a thickness of about 3 to 6 mm was used as the thermoplastic sheet T.

The completed thermoplastic model Mt is cut along the horizontal direction by a cutter or the like, separated into the sole mounting portion 2 and the lower leg mounting portion 3, and the thermoplastic model Mt is separated from the positive model Mp. The cut at this time is cut so as to pass through the substantially central portion of the foot medial recess 101 recessed by the first dummy portion 10 and the foot lateral recess 111 recessed by the second dummy portion 11. (See FIG. 5D), as shown in FIGS. 1 to 4, the medial foot recess 101 is separated into a first medial foot recess 23 and a second medial foot 33, and the lateral foot 111 is a first. It is separated into a foot lateral recess 24 and a second foot lateral recess 34.

<Process 11 Installation of each member>
For the thermoplastic model Mt separated into the sole mounting portion 2 and the lower leg mounting portion 3, the in-foot connecting portion 4, the external connecting portion 5, and the plantar flexing braking portion 6 are attached, respectively. At this time, the fastening portion 7 of the inward connecting portion 4 corresponds to a position substantially corresponding to the inner fruit end point of the affected foot, and the fastening portion 7 of the outer foot connecting portion corresponds to a position substantially corresponding to the outer fruit end point of the affected foot. By attaching the foot in this way, the rotation axis a1 of the in-foot connecting portion 4 substantially corresponds to the inner fruit end point of the affected foot, and the rotation shaft a2 of the outer-foot connecting portion 5 substantially corresponds to the outer fruit end point of the affected foot. Therefore, smooth plantar dorsiflexion movement can be realized without inhibiting the supination and inward action of the affected foot.

As described above, in the method for manufacturing an ankle foot orthotic device to which the present invention is applied and the ankle foot orthotic device, the supination action and the supination action of the foot can be promoted.

1 Ankle foot equipment 2 Foot sole mounting part 21 Foot resting part 22 Foot covering part 23 First foot medial recess 24 Second foot lateral recess 25 First belt body 3 Lower leg mounting part 31 Lower leg rear surface contact part 32 Lower leg Side contact part 33 First foot medial recess 34 Second foot lateral recess 35 Second belt body 4 In-foot connection 41 First in-foot connection 42 Second in-foot connection 5 Out-of-foot connection 51 First foot outer connection part 511 First foot outer convex part 512 First foot outer concave part 513 First foot outer step part 514 Mounting hole 52 Second foot outer connection part 521 Second foot outer convex part 522 Second foot outer recess 523 Second foot step part 524 Mounting hole 6 Bottom bending braking part 61 First cylindrical part 62 Pressing receiving part 63 Second cylindrical part 64 Pressing part 7 Fastening part 71a, 71b, 71c Bolt 711 Hexagonal hole 712 Male screw 72 Nut 721 Convex pillar part 722 Female screw 8 Rod-shaped member 9 Spacer 10 First dummy part 101 Inward foot concave part 11 Second dummy part 111 Outer foot concave part 12 Third dummy part a1, a2 Rotating axis H Horizontal axis G Gypsum L Virtual straight line Mn Negative model Mp Positive model Mt Thermoplastic model S Suction pipe T Thermoplastic sheet

Claims (10)

The process of wrapping a cast bandage around the affected foot and molding it into the shape of the affected foot,
The process of removing the hardened cast bandage from the affected foot and molding a negative model,
In the negative model, a step of piercing an inner fruit hole at a position substantially corresponding to the inner fruit end point of the affected foot and an outer fruit hole at a position substantially corresponding to the outer fruit end point of the affected foot.
A step of inserting a rod-shaped member from either one side of the inner fruit hole portion or the outer fruit hole portion toward the other side, and
The process of pouring gypsum into the negative model, curing it, and molding the positive model,
A step of inserting one end side of the rod-shaped member into a through hole formed at a predetermined position of a first dummy portion made of a plate-shaped body and attaching the first dummy portion to the inside of the foot of the positive model.
A step of inserting the other end side of the rod-shaped member into a through hole formed at a predetermined position of a second dummy portion made of a plate-shaped body and attaching the second dummy portion to the outside of the foot of the positive model.
The process of extracting the rod-shaped member from the positive model and
The process of coating the positive model with the laminate and
The process of forming a thermoplastic model by covering the positive model with a thermoplastic sheet and vacuum forming it,
A method of manufacturing an ankle foot orthotic device comprising a step of removing the thermoplastic model from the positive model. The step of removing the thermoplastic model from the positive model is
The method for manufacturing an ankle foot orthotic device according to claim 1, further comprising a step of separating the thermoplastic model into a sole mounting portion and a lower leg mounting portion by making a cut along the circumferential direction of the thermoplastic model. The step of separating the thermoplastic model into a lower leg mounting part and a sole mounting part is
The medial foot recessed in the thermoplastic model at the position corresponding to the first dummy portion is the first medial recess on the sole mounting portion side and the second foot on the lower leg mounting portion side. The foot lateral recess, which is separated into the medial recess and is recessed in the thermoplastic model at a position corresponding to the second dummy portion, is the first foot lateral recess on the sole mounting portion side and the lower leg mounting portion. The method for manufacturing an ankle foot device according to claim 2, further comprising a step of separating into a second lateral foot recess on the side. The step of attaching the first dummy portion to the medial side of the foot of the positive model is as follows.
A step of interposing a first spacer between the first dummy portion and the positive model is provided.
The step of attaching the second dummy portion to the outside of the foot of the positive model is as follows.
The method for manufacturing an ankle foot orthotic device according to any one of claims 1 to 3, further comprising a step of interposing a second spacer between the second dummy portion and the positive model. After the step of extracting the rod-shaped member from the positive model and before the step of coating the positive model with the laminate.
The method for manufacturing an ankle foot orthotic device according to any one of claims 1 to 4, which comprises a step of wrapping a wrap film around the positive model. After the step of coating the laminate on the positive model and before the step of vacuum forming the thermoplastic resin and molding the thermoplastic model.
The method for manufacturing an ankle foot orthotic device according to any one of claims 1 to 5, further comprising a step of attaching a substantially columnar third dummy portion at a position substantially corresponding to the Achilles tendon portion of the positive model. The step of removing the thermoplastic model from the positive model is
The sixth aspect of claim 6 includes a step of separating a cylindrical portion formed along the shape of the third dummy portion into a first cylindrical portion on the sole mounting portion side and a second cylindrical portion on the lower leg mounting portion side. How to make ankle foot orthotic devices. The sole mounting part to be mounted on the sole and the sole mounting part
The lower leg attachment part to be attached to the lower leg and the lower leg attachment part
The first foot includes a first in-foot connecting portion connected to the medial side of the sole mounting portion on one side, and a second in-foot connecting portion connected to the medial side of the foot of the lower leg mounting portion on one side. The other side facing one side of the inner connecting part and the other side facing one side of the second foot connecting part are rotatably supported at a position substantially corresponding to the inner fruit end point. ,
The first foot includes a first extrafoot connection portion connected to the lateral side of the sole mounting portion on one side, and a second extrafoot connecting portion connected to the lateral side of the foot mounting portion on one side. The other side facing one side of the outer connecting portion and the other side facing one side of the second foot outer connecting portion are rotatably supported at a position substantially corresponding to the outer malleolus end point. In the ankle foot orthotic device equipped with,
The in-foot connecting portion is
Other than the first in-foot step portion, which is the other side of the first in-foot connecting portion and is formed from the first in-foot convex portion and the first in-foot concave portion, and the second in-foot connecting portion. The second in-foot step portion formed from the second in-foot convex portion and the second in-foot concave portion on the side is unevenly fitted so as to be alternately meshed on the same plane.
The extrafoot connection portion is
Other than the first foot outer step portion, which is the other side of the first foot outer connection portion and is formed from the first foot outer convex portion and the first foot outer concave portion, and the second foot outer connection portion. The second foot outer step portion formed from the second foot outer convex portion and the second foot outer concave portion on the side is unevenly fitted so as to be alternately meshed on the same plane.
Ankle foot orthotic device. The virtual straight line connecting the rotation axis of the in-foot connection portion and the rotation axis of the outer-foot connection portion has an inclination angle of approximately 8 to 13 ° with respect to the horizontal axis.
The ankle foot orthotic device according to claim 8 . A pressing portion made of an elastic material at a position substantially corresponding to the Achilles tendon portion of the lower leg mounting portion, and a pressing receiving portion pressed by the pressing portion at a position substantially corresponding to the Achilles tendon portion of the sole mounting portion and elastically deformable. Has a plantar flexion braking part including
The ankle foot orthotic device according to claim 8 or 9 .

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